Skip to content

Development, Implementation and Initiation of Normative Database Quantitative Ultra High Field MRI Paramaters

Development, Implementation and Initiation of Normative Database Quantitative Ultra High Field MRI Paramaters

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02402751
Enrollment
400
Registered
2015-03-30
Start date
2015-03-31
Completion date
2019-09-30
Last updated
2016-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Volunteers

Brief summary

The Centre for Magnetic Resonance in Biology and Medicine (CRMBM, UMR-CNRS 7339 AMU) obtained funding for a whole body NMR imaging at 7. It is the only MRI at 7T installed in a hospital in France (only two 7T MRI in France) and therefore a unique opportunity to develop new diagnostic approaches. The purpose of this study is to develop, implement and validate new MRI quantitative parameters derived from ultra high field MRI in order to characterize non-invasively with an unprecedented resolution and sensitivity, anatomy as well as certain physiological, hemodynamic and metabolic function of brain, spinal cord, musculoskeletal system, and heart in healthy subjects

Detailed description

The key is that the goal of our projects is not only producing images of better quality than using a 3T scanner but also making images differently, by highlighting new contrasts and features of theses organs in order to improve the diagnosis and prognosis of neurological, psychiatric, cardiovascular and rheumatologic diseases.

Interventions

PROCEDUREacquisition of normative database with ultra high field MRI

characterize non-invasively with an unprecedented resolution and sensitivity (high field MRI), anatomy as well as certain physiological, hemodynamic and metabolic function of brain, spinal cord, musculoskeletal system, and heart

DEVICEMRI

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* People not presenting contraindications to the MRI (pacemaker, agitation, metallic brightness, claustrophobia etc.) * People having no intra-physical object potentially conductive. * People having no affection after detailed interrogation

Exclusion criteria

* People staying in a sanitary or social establishment * People in emergency situation * People not wishing to be informed about anomalies in the MRI * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
qualitative validation concerning structure visible with high field MRI4 yearsthe validation criteria are qualitative (contrast and visibility of anatomical structures usually visible 7T but not visible at 3T will be used to assess the sensitivity of images for each modality) and quantitative (signal to noise ratio (SNR), spatial and temporal resolution).

Secondary

MeasureTime frameDescription
acquisition of normative data and verification of the quality criteria obtained during the first phase4 yearsDuring the second phase, we will acquire normative data and verify the quality criteria of the first phase. Each quantitative variable will be extracted. After the acquisition of the first 30 volunteers for each parameter, the variance will be analyzed to assess the population distribution. Depending on the results, and issues raised by clinical research studies, other populations will be acquired

Countries

France

Contacts

Primary ContactMaxime GUYE, M.D
mgue@ap-hm.fr
Backup ContactAlexandra GIULIANI
agiuliani@ap-hm.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026